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Trial Title:
Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
NCT ID:
NCT06254859
Condition:
Thyroid Cancer
Thyroid Cancer, Papillary
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Conditions: Keywords:
acoustic analysis
thyroid cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Traditional thyroid surgery.
Description:
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve
monitoring technology.
Arm group label:
Normal Signal Group.
Arm group label:
Signal Absence Group.
Arm group label:
Signal Decrease 10-50%.
Arm group label:
Signal Decrease 50-90%.
Summary:
This study examines the impact of intraoperative recurrent laryngeal nerve monitoring
signal changes on the postoperative voice quality of thyroid surgery patients. By
analyzing extensive surgical data and postoperative voice recordings, the investigation
seeks to identify patterns in the variations of these signals and their correlation with
voice quality outcomes. The goal is to enhance clinical understanding and surgical
practices, allowing for more precise assessments of nerve function, informed surgical
interventions, and improved postoperative patient well-being.
Detailed description:
This research project conducts a detailed exploration into the fluctuations of
intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and
their subsequent effects on the voice quality of patients after surgery. The study
meticulously analyzes a comprehensive dataset comprised of surgical records and voice
analyses conducted before and after the procedure. The primary objective is to pinpoint
specific trends and changes in the nerve monitoring signals and to determine how these
alterations correlate with the postoperative acoustic characteristics of patients'
voices. By establishing a clear link between intraoperative signal dynamics and
postoperative voice outcomes, the investigation aims to advance the field of thyroid
surgery. This includes providing surgeons with critical insights for the precise
evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions
during operations, and ultimately contributing to the enhancement of patients' quality of
life following surgery. Through this rigorous analysis, the study seeks to contribute
valuable knowledge to the surgical community, facilitating improved patient care and
outcomes in thyroid surgery.
Criteria for eligibility:
Study pop:
People with thyroid cancer who are planned to undergo traditional surgical treatment.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age 20-60 years old.
- Planned conventional unilateral thyroid lobectomy + isthmus resection + central
compartment lymph node dissection.
Exclusion Criteria:
- History of past head and neck surgeries.
- Pronunciation system defect and disorder history.
- History of vocal cord polyps or nodules.
- History of upper respiratory tract infection in the 2 weeks before surgery or
postoperative infection history.
- History of neurological disorders.
- Abnormalities in the throat.
- Preoperative damage to throat morphology or motor function.
- Preoperative functional voice or language disorders, noticeable hoarseness, or
difficulty in pronunciation.
- Pre- and postoperative laryngoscopic examination showing vocal cord paralysis and
arytenoid joint dislocation.
- Neurological disorders causing abnormal throat function.
- Patient unable to cooperate with VHI (Voice Handicap Index) assessment and voice
spectrum examination.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Wang Porfessor, MD
Phone:
+13959123550
Email:
wangbo@fjmu.edu.cn
Investigator:
Last name:
Bo Wang, MD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fujian Medical University
Agency class:
Other
Source:
Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254859